Advanced Colorectal CancerPhase 1NCT07178613
Assessment of the Dose Safety and Efficacy of Serine Combined With Fluorouracil Drugs
A Phase 1 study testing Serine（Oral） and Fluoropyrimidine Drugs in people with Advanced Colorectal Cancer, run by The First Affiliated Hospital of Xinxiang Medical College.
Trial summary
This study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration. Secondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- Serine（Oral） and Fluoropyrimidine Drugs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Feb 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years (inclusive), male or female;
- Patients with advanced colorectal cancer confirmed by histopathological or cytological examination, eligible for standard first-line treatment with fluorouracil-containing regimens.
- Patients must have at least one measurable lesion.
- ECOG performance status ≤ 2.
- Expected survival ≥ 3 months;
- Major organ functions are essentially normal, with laboratory tests meeting the following criteria:
Show all 18Show fewer
- Hematology (no transfusion of blood or blood products within 7 days prior to testing; no use of G-CSF or other hematopoietic growth factors for correction):
- Absolute neutrophil count ≥1.5×10⁹/L ; Platelets ≥75×10⁹/L ; Hemoglobin ≥90 g/L;
- Renal:
- Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m² (Cockcroft-Gault formula);
- Liver:
- Serum total bilirubin <1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5×ULN or ≤5×ULN (for subjects with liver metastases); Albumin (ALB) ≥30 g/L;
- Coagulation Function:
- International Normalized Ratio (INR) or Prothrombin Time (PT) < 1.5×ULN. If the subject is receiving anticoagulant therapy, PT is acceptable as long as it falls within the therapeutic range for the anticoagulant drug.
- Cardiovascular System:
- Ejection Fraction (EF) 55%-70%; QTc Interval: Male ≤440ms; Female ≤450ms.
- Serum pregnancy tests for female subjects of childbearing potential during the screening period must be negative. Female/male subjects with reproductive potential must be willing to use reliable contraception throughout the study period (i.e., from signing the informed consent form until 90 days after the last study drug administration), including but not limited to: abstinence, male partner having undergone vasectomy, female sterilization, effective intrauterine device (IUD), and effective contraceptive medication.
- Patients voluntarily participate in this study, sign informed consent forms, and demonstrate good compliance.
Who cannot join
- Trial Participation Restrictions: Currently participating in or having received investigational drug/device treatment within the past 4 weeks;
- Prior Fluorouracil-Based Therapy Restrictions: History of ≥Grade 3 toxicity (e.g., myelosuppression, gastrointestinal toxicity) following prior fluorouracil-based therapy, deemed unsuitable for re-administration by the investigator;
- Recent Surgery Restriction: Undergone major surgery (excluding diagnostic biopsy) within 28 days prior to first dosing, or scheduled for surgery during the study period;
- Metabolic and Nutritional Status Restriction: Presence of severe malnutrition (BMI < 18.5 or serum albumin < 30 g/L), or inability to supplement serine orally (e.g., malabsorption syndrome, short bowel syndrome); Known serine metabolism disorders (e.g., PHGDH/PSAT1 gene mutation-related diseases);
- Concurrent severe disease restrictions: Severe cardiovascular disease (NYHA Class III/IV heart failure, myocardial infarction within 6 months, uncontrolled hypertension >150/100 mmHg); severe respiratory disease (COPD, GOLD Stage ≥3, interstitial lung disease); Active infection (requiring systemic antibiotic/antiviral therapy);
- Active HIV/viral hepatitis: HIV-positive status, or active hepatitis B (HBV-DNA ≥ 2000 IU/mL), or active hepatitis C (HCV-RNA positive); (Note: Patients with HBV-DNA < 2000 IU/mL receiving antiviral therapy may be enrolled);
Show all 10Show fewer
- Neurological disorders: Uncontrolled brain metastases (with intracranial hypertension or neurological symptoms), or history of severe psychiatric illness/substance abuse (impeding treatment compliance);
- Allergy history: Known allergy to fluorouracil-based drugs or serine supplements;
- Pregnancy/lactation: Pregnant or lactating women (patients of childbearing potential must use highly effective contraception);
- Other conditions deemed ineligible by the investigator: Any concomitant conditions or laboratory abnormalities that may interfere with study results, increase risk, or compromise patient safety.
About this study
This study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration.
Secondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. To establish the recommended Phase 2 dose for oral serine.
- Conditions
- Advanced Colorectal Cancer
- Being tested
- Serine（Oral）, Fluoropyrimidine Drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serine（Oral）Drug
This study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration.
Secondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. To establish the recommended Phase 2 dose for oral serine.
Fluoropyrimidine DrugsDrug
This study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration.
Secondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. To establish the recommended Phase 2 dose for oral serine.
| Study group | Role | What they receive |
|---|---|---|
| Serine + Fluoropyrimidine Group | Other | Not described Receives: Drug: Serine（Oral）; Drug: Fluoropyrimidine Drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Oral Serine
Assess the safety of oral serine, including the occurrence of adverse events and dose - limiting toxicities
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study startNov 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178613
- Sponsor's protocol ID
- EC-2025-19
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Dose Safety and Efficacy of Serine Combined With Fluorouracil Drugs
- ClinicalTrials.gov ID
- NCT07178613
- Acronym / sponsor ID
- EC-2025-19
- Conditions
- Advanced Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration.
Secondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. To establish the recommended Phase 2 dose for oral serine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serine + Fluoropyrimidine Group | Other | Drug: Serine（Oral）, Drug: Fluoropyrimidine Drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 years (inclusive), male or female;
- Patients with advanced colorectal cancer confirmed by histopathological or cytological examination, eligible for standard first-line treatment with fluorouracil-containing regimens.
- Patients must have at least one measurable lesion.
- ECOG performance status ≤ 2.
- Expected survival ≥ 3 months;
Key exclusion criteria (10 listed)
- Trial Participation Restrictions: Currently participating in or having received investigational drug/device treatment within the past 4 weeks;
- Prior Fluorouracil-Based Therapy Restrictions: History of ≥Grade 3 toxicity (e.g., myelosuppression, gastrointestinal toxicity) following prior fluorouracil-based therapy, deemed unsuitable for re-administration by the investigator;
- Recent Surgery Restriction: Undergone major surgery (excluding diagnostic biopsy) within 28 days prior to first dosing, or scheduled for surgery during the study period;
- Metabolic and Nutritional Status Restriction: Presence of severe malnutrition (BMI < 18.5 or serum albumin < 30 g/L), or inability to supplement serine orally (e.g., malabsorption syndrome, short bowel syndrome); Known serine metabolism disorders (e.g., PHGDH/PSAT1 gene mutation-related diseases);
- Concurrent severe disease restrictions: Severe cardiovascular disease (NYHA Class III/IV heart failure, myocardial infarction within 6 months, uncontrolled hypertension >150/100 mmHg); severe respiratory disease (COPD, GOLD Stage ≥3, interstitial lung disease); Active infection (requiring systemic antibiotic/antiviral therapy);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serine（Oral）This study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration. Secondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. To establish the recommended Phase 2 dose for oral serine. | Drug | Serine + Fluoropyrimidine Group |
| Fluoropyrimidine DrugsThis study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration. Secondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. To establish the recommended Phase 2 dose for oral serine. | Drug | Serine + Fluoropyrimidine Group |
Primary outcome
Safety of Oral Serine
Time frame: Up to 28 days
Assess the safety of oral serine, including the occurrence of adverse events and dose - limiting toxicities
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
Related trials for Advanced Colorectal Cancer
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Not yet recruitingObservational study
Multidimensional Study Designed to Develop a Methodological Framework Based on MRI Data to Predict Pathological Complete Response (pCR) in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Treatment
Rectal Cancer, Chemoradiotherapy
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Serine（Oral） and Fluoropyrimidine Drugs in people with Advanced Colorectal Cancer, run by The First Affiliated Hospital of Xinxiang Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Oral Serine (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.